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Global Regulatory Considerations for Biosimilar Approval

Time

Wed, Jun 18 7:15AM
W 31

Title

Global Regulatory Considerations for Biosimilar Approval

Abstract Summary

A literature review and analysis of the current state of biosimilar legislation, guidance, and approvals. Published articles; competent authoritiy guidance and/or approvals; WHO and ICH Comparability Guidelines; and company websites.

Poster Presenter

Holly Groelle
PhD,
Principal Regulatory Affairs Specialist,
PPD
United States